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Sealed Therapeutic Shoe as Treatment of Diabetic Foot Ulcers

NCT04085926 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2025-05-31

No results posted yet for this study

Summary

Total contact casts (TCCs) are effective treatment of plantar diabetic foot ulcers because they effectively offload the ulcer and are non-removable, resulting in high adherence to using the device. However, TCCs are not widely used in clinical practice because they negatively impact gait and daily activities. A new treatment concept was invented, sealed therapeutic shoe, where a shoe with a custom-made insole offloads the ulcer, and the shoe is rendered irremovable to be worn day and night, like a TCC.

In this multicenter randomized controlled trial (RCT), 150 participants will be recruited and randomized to two treatment arms: TCC or sealed therapeutic shoe. The primary outcome is ulcer healing, secondary outcomes include (but are not limited to) skin complications, glycemic control, body mass index, gait function, balance, quality of life, physical activity, and health economics.

Conditions

  • Diabetic Foot

Interventions

DEVICE

Sealed therapeutic shoe

Off-the-shelf therapeutic shoe and custom-made insole

DEVICE

Total contact cast

Custom-made total contact cast

Sponsors & Collaborators

  • Forte

    collaborator INDUSTRY

  • Region Örebro County

    lead OTHER

Principal Investigators

  • Gustav Jarl, PhD · University Health Care Research Center, Region Örebro county

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-16
Primary Completion
2022-02-01
Completion
2022-02-01

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04085926 on ClinicalTrials.gov